On December 28, 2021, the FDA updated the emergency use authorization (EUA) for COVID-19 convalescent plasma. The update limits the authorization to the use of COVID-19 convalescent plasma with high titers of anti -SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or who are receiving immunosuppressive treatment. Additionally, to help assure the manufacture of high titer COVID-19 convalescent plasma, the revisions to the EUA define acceptable tests and increase qualifying result cutoffs to be used for manufacturing COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies.
We are currently evaluating our options to determine if we can provide additional testing services using one of the newly defined assays. Please reach out to your customer service manager if your organization is considering CCP testing under the updated guidelines.
FDA Guidance titled “Further Testing of Donations that are Reactive on a Licensed Donor Screen...
We received an updated WNV package insert; please note the manufacturer and license number has been ...
We are very excited to launch our new website! Please take a few moments to click around and explore...
CTS Dallas and Phoenix Labs successfully implemented WNV NAT testing on the Panther Testing Platform...
On Wednesday August 15, 2018 at 11:00AM PDT, we will be hosting a webinar regarding the changes to F...
A new Learning Center website will launch on Monday, March 30, 2020. While the link to the new Learn...